A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour

An Open, Multicenter Phase I Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-7058 Monotherapy in Patients With Advanced Solid Tumour With KRAS G12C Mutation

This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Tumour
• Intervention / Treatment: Drug: HRS-7058 capsule/ HRS-7058 tablet

• Study Type: Interventional
• Enrollment (Estimated): 233
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yifan Zhang; Phone Number: +0518-81220121; Email: yifan.zhang.yz597@hengrui.com
• Study Contact Backup: Name: Keke Yan; Phone Number: +0518-81220121; Email: keke.yan@hengrui.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Principal Investigator: Dingzhi Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;
2. 18 to 75 years old (including both ends), gender is not limited;
3. Subjects with locally advanced or metastatic solid tumour confirmed by histopathology;
4. Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1);
5. ECOG Performance Status of 0 or 1;
6. The expected survival time is more than 3 months;
7. Be able to ingest drugs and be able to comply with trial and follow-up procedures;
8. Adequate bone marrow and organ function;
9. Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse) or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug. The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;
10. For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.

Exclusion Criteria:

1. Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
2. Had other malignancies within five years prior to first use of the investigational drug;
3. With severe cardiovascular and cerebrovascular disease；
4. Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
5. The presence of uncontrolled pleural, abdominal or pericardial effusion;
6. Severe infection within 4 weeks prior to initiation of study treatment;
7. History of immune deficiency;
8. The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1;
9. Antitumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other unmarketed investigational drug therapy within 4 weeks prior to initial use of the investigational drug;
10. Had undergone major organ surgery within 4 weeks prior to the first use of the study drug;
11. Women who are pregnant, breastfeeding, or who plan to become pregnant within one week of their last use of the study drug during the study period;
12. Known allergies and contraindications to the investigational drug or any of its components;
13. In the investigator's judgment, the subjects had other factors that could have affected the study results or led to the forced termination of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-7058	Drug: HRS-7058 capsule/ HRS-7058 tablet; HRS-7058 capsule/ HRS-7058 tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose-limiting toxicity (DLT)	From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
maximum tolerated dose (MTD)	From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Phase II recommended dose (RP2D)	From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Safety endpoints: adverse events (AE)	From the beginning of first patient in (FPI) to the end of study up to approximately 21 months]

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion	From the beginning of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion	From the beginning of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion	From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion	From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: overall survival (OS)	From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HRS-7058-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No